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The Model ORCA-2016CN is a portable and ambulatory Patient Isolation Unit (PIU) designed to prevent chemical and particulate (biological and radiological) cross-contamination between an enclosed contaminated patient and the external environment during evacuation and transport activities.

The Operational Rescue Containment Apparatus (ORCATM) Patient Isolation Unit, Model ORCA-2016CN, is a tubular, flexible, Patient Isolation Unit (PIU) for use during transport and evacuation of chemical and particulate (biological and radiological) contaminated patients who have been medically stabilized. Each unit employs clear windows to allow visual monitoring of the patient. The unit incorporates multiple glove arms for minimal medical intervention. The PIU's have a reinforced base mat with integrated carry straps and tethers to enable lifting and attachment to a Stokes litter for hoisting operations or a North Atlantic Treaty Organization (NATO) litter for alternative transportation. Chamber airflow through the isolator and across the patient is provided by the blower from a Powered Air-Purifying Respirator (PAPR). Internal contaminated air in the PIU is vented out the exhaust ports which are fitted with two Chemical, Biological, Radiological, Nuclear (CBRN) filter cartridges, thus protecting the external environment from a contaminated patient.

The provided text describes the ISOVAC Products, LLC ORCA™ - Operational Rescue Containment Apparatus (K163223), a patient isolation unit. However, the document does not contain information relevant to all parts of the request. Specifically, it does not detail a study involving an algorithm or artificial intelligence, a common scenario for multi-reader multi-case (MRMC) comparative effectiveness studies. Therefore, some sections of your request cannot be fully addressed from the provided text.

Here's an analysis of the acceptance criteria and performance data available in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for each performance test in a formal table format with numerical targets. Instead, it describes tests performed and their successful outcomes, implying that successful completion of these tests serves as the acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance

• Operational Testing: The document mentions "multiple times" for hoisting. It doesn't specify a numerical sample size for the tests on the PIU during helicopter operations.
  • Data Provenance: Conducted by the U.S. Coast Guard, suggesting a domestic (USA) origin. The nature of the test (actual helicopter operations) implies prospective testing for the specific device, though it's evaluating a physical product's performance rather than data analysis.
• Chemical Agent Permeation, Liquid Penetration / Pathogen Passage, Human Use Comfort, Weight Lift Testing: These were performed by a "third-party testing party under contract with the USGC." No specific numerical sample sizes are given for the number of units tested or the number of samples for materials.
  • Data Provenance: The location of the third-party testing party is not specified, but the USGC contract suggests it's likely within the US. These tests are prospective.
• Human Use Comfort: "a test participant (TP)" was used, indicating a sample size of 1 for the comfort study.
  • Data Provenance: Not explicitly stated, but likely domestic (USA) given the context. Prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable as the document describes performance testing of a physical medical device (Patient Isolation Unit), not an AI or algorithm-based device that would require expert consensus for establishing ground truth data. The "ground truth" for these tests is based on objective measurements (e.g., lack of permeation, stable vitals, weight holding capacity) and successful operational use as determined by the USCG.

4. Adjudication Method for the Test Set

This is not applicable for the type of device and testing described. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving interpretation of medical data by multiple experts to establish a "true" label, which is not the nature of the tests conducted for this physical device. The USCG "deemed...sufficient testing" for the operational tests, indicating their internal expert judgment as an adjudicator, but not in the sense of a medical image or diagnostic interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices where human readers interpret medical cases with and without AI assistance. The ORCA™ is a physical containment apparatus.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone (algorithm only) performance study was not done. The ORCA™ is a physical medical device and does not involve an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the tests described is primarily based on:

• Objective performance measurements: For chemical permeation, liquid penetration, vital signs, and weight capacity. These are quantifiable outcomes.
• Operational success/validation: For hoisting and transport, determined by the U.S. Coast Guard's assessment of suitability for use in their aircraft.

8. The Sample Size for the Training Set

Not Applicable. The ORCA™ is a physical medical device, not an AI or algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. As mentioned above, there is no AI or algorithm with a training set for this device.

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The ORCA-DX® Bone Densitometer provides an estimate of BMD for the heel and forearm.
The ORCA-DX® Bone Densitometer requires a 4-second exposure for BMD with a skin entrance dose of

The ORCA-DX Bone Densitometer provides an estimation of Bone Mineral Density (BMD in g/cm2) for the heel and forearm, using dual-energy x-ray absorptiometry.

Here's a breakdown of the acceptance criteria and study information for the LUNAR ORCA-DX Bone Densitometer, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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The ORCA System is indicated for use in exercise tests where the collection and analysis of gas exchange and extraction of pulse rate information from ECG during exercise stress testing is needed. Further, the device will suggest interpretive statements based on the results of the analysis and the reasons for the test termination. The intended patients are adults and children and the intended environment of use is indoors.

The ORCA Cardiopulmonary Exercise Testing System is a self-contained unit designed to provide patient respiratory gas exchange data during exercise stress testing. The system consists of components which measure the flow of exhaled air, and analyze the oxygen and carbon dioxide content of the exhaled air. A transcutaneous pulse oximeter reports heart rate and oxygen content of the arterial blood. Instruments are interfaced to a Pentium-based personal computer through a 16 channel, 12 bit analog/digital converter. As an option, information can be integrated with electrocardiographic information provided by external EKG equipment (EKG equipment is not provided with the ORCA system). Software collects and analyzes data, summarizes results and suggests possible implications of abnormalities observed.

The provided text describes the ORCA Cardiopulmonary Exercise Testing System and its substantial equivalence to predicate devices, but it does not contain detailed information about specific acceptance criteria, comprehensive device performance data, or a study report with methodological details commonly found for proving such criteria.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to legally marketed predicate devices rather than providing a standalone clinical study report with detailed performance metrics. Therefore, many of the requested details are not explicitly present in the provided text.

Based on the available information, here's what can be inferred and what is missing:

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

The document primarily focuses on establishing substantial equivalence to predicate devices rather than detailing specific, quantified acceptance criteria and a study to prove the device meets these criteria as if it were a novel device requiring de novo authorization.

The "acceptance criteria" here are implicitly related to the device having similar performance, features, and intended use as the predicate devices (MedGraphics Exercise Consult K923209 and Sensormedics Vmax 229 K942211). The "study" proving this is the 510(k) submission itself, which argues for substantial equivalence by comparing the ORCA system to these predicates.

1. A table of acceptance criteria and the reported device performance

Since the regulatory pathway is 510(k) and focuses on substantial equivalence, explicit quantitative acceptance criteria for performance metrics in a pass/fail format are not presented. Instead, the document compares the features and intended use of the ORCA system to its predicates.

Missing Information: Quantitative performance metrics (e.g., accuracy, precision, repeatability for O2/CO2 measurement, flow measurement, pulse rate measurement, or the interpretive statements' accuracy) are not provided in this 510(k) summary. The "acceptance criteria" appear to be met by demonstrating similar functionality and intended use to the predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the 510(k) summary. The document does not describe a specific clinical "test set" and study data for the ORCA system in the way a clinical trial would. The basis for equivalence is primarily a comparison of device specifications and intended use against existing, cleared devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable/not provided by the document. The 510(k) summary does not describe a process of establishing ground truth with experts for a test set, as would be done for an AI diagnostic device requiring such validation. The interpretive statements feature is mentioned, but its validation methodology isn't detailed here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/not provided by the document. There is no mention of a test set requiring adjudication in this 510(k) summary.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable/not provided by the document. The ORCA system is described as generating interpretive statements, but not as an "AI assistance" device in the context of improving human reader performance via an MRMC study. It's a system to collect and analyze physiological data and provide interpretive statements based on that analysis.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device is described as assisting in "collection and analysis of gas exchange and extraction of pulse rate information" and will "suggest interpretive statements." This suggests a standalone analytical component. However, specific standalone performance metrics (e.g., accuracy of interpretation) are not detailed in the provided summary. The focus is on the device as a whole system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not provided for any validation of the interpretive statements. For the measurements (O2, CO2, flow, pulse rate), the implied "ground truth" would likely be comparison to reference measurement devices or established calibration standards, but specifics are missing from this summary.

8. The sample size for the training set

This information is not provided. The 510(k) summary does not mention a "training set," implying that if any algorithms are used for interpretation, they are based on established physiological models or rules rather than machine learning trained on a dataset.

9. How the ground truth for the training set was established

This information is not applicable/not provided. Without a mention of a training set, there's no information on how its ground truth would have been established.

In summary: The provided 510(k) document serves to demonstrate substantial equivalence based on device features and intended use, rather than a detailed performance study with explicit acceptance criteria and validation data as typically required for novel or high-risk devices or AI/ML-enabled devices today. The "study" for acceptance here is the comparison presented in the 510(k) application itself, aligning the ORCA system's attributes with those of the predicate devices.

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The ORCA is a small image intensibled fluoroscopic C-Arm, for imaging extremities in orthopedic applications. The ORCA Operator's manual contains the following statement: "CAUTION: Federal Law (USA) restricts this device to sale and use by or on the order of a physician."

The ORCA is a small image intensified fluoroscopic C-Arm, for imaging extremities in orthopedic applications.

The provided text is a 510(k) summary for a medical device called ORCA, an image-intensified fluoroscopic C-Arm. The purpose of this document is to demonstrate "substantial equivalence" to a predicate device, not necessarily to prove the device meets specific acceptance criteria through a clinical study with detailed performance metrics.

Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not present in the provided text.

The document focuses on comparing the technical characteristics of the ORCA to a predicate device (OEC Medical Systems Inc. Series 6600 Digital Mobile C-Arm) to establish substantial equivalence.

Here's a breakdown of what is available from the text and why the requested information is absent:

1. A table of acceptance criteria and the reported device performance:
   • Acceptance Criteria/Performance: The document presents a "Summary of Technical Characteristics" table comparing features of the ORCA to its predicate device. This table effectively is the "performance" data used to argue for substantial equivalence, rather than a separate set of acceptance criteria based on clinical outcomes. For example, it compares X-Ray source specifications (e.g., 0.3mm focal spot vs. 0.25mm), image intensifier size (6 inch vs. 4 or 6 inch), and scatter radiation to operator (

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